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使用通用反向全肩关节系统治疗肱骨近端骨折的反向全肩关节置换术后,侧方移位和远侧移位对结节愈合及功能结果的影响:一项比较135°和155°非骨水泥柄的随机对照试验

Effect of Lateralization and Distalization on Tuberosity Healing and Functional Outcomes After Reverse Total Shoulder Arthroplasty with Univers Revers Total Shoulder System for Proximal Humerus Fractures: A Randomized Controlled Trial Comparing 135° and 155° Uncemented Stems.

作者信息

Rius Xavi, Gonzalez-Morgado Diego, Matellanes Jonathan, Luzardo Ana, Agullo Jose Luis, Hachem Abdul-Ilah

机构信息

Orthopaedic Surgery Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Universitat de Barcelona (UB), Barcelona, Spain.

Orthopaedic Surgery Department, Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain.

出版信息

J Shoulder Elbow Surg. 2025 Sep 10. doi: 10.1016/j.jse.2025.07.033.

Abstract

BACKGROUND

Controversy remains regarding whether humeral neck shaft angle influences tuberosity healing in reverse total shoulder arthroplasty (rTSA) for proximal humerus fracture (PHF). This study aimed to compare the tuberosity healing rates between rTSA using a lateralized and a distalized configuration of the Univers Revers Total Shoulder System for PHFs. The secondary objective was to evaluate functional outcomes based on stem inclination and tuberosity healing status.

METHODS

This randomized controlled trial enrolled patients ≥65 years with Neer 3- or 4-part PHF or a displaced Neer 2-part PHF with osteoporosis and/or a rotator cuff tear. Patients were randomized into two groups: 135° stem with 4 mm of lateralization or 155° stem with 2.5 mm of distalization. A priori power analysis determined a sample size of 78 patients to detect a 15% difference in tuberosity healing between groups with statistical significance. Healing of the tuberosities was assessed by two independent shoulder surgeons on radiographs at 6, 12, and 24 months postoperatively. Range of motion (ROM) and patient-reported outcomes (PROs) were compared. PROs included Visual Analogue Scale for pain (VAS), Constant-Murley score (CMS), and Quick-DASH (Disabilities of the Arm, Shoulder and Hand). Post-hoc analyses compared outcomes by greater tuberosity healing and implant configuration.

RESULTS

A total of 79 patients were enrolled, and 38 in each group completed at least a 2-year follow-up. Non-healing of the greater tuberosity occurred in 3 patients in the 155°-distalized group and 12 in the 135°-lateralized group (P=.009). The relative risk of greater tuberosity non-healing in the 135°-lateralized group compared to the 155°-distalized group was 4.0 (95% CI: 1.23-13.05, P=.022) at 24 months. ROM and PROs were similar between groups (P>.050). In non-healed greater tuberosity cases, the 155°-distalized configuration showed significantly lower ER than the 135°-lateralized (-17° ± 6 vs. 15° ± 19, P=.006). No significant differences in ROM and PROs were found between implant types in healed cases (P>.050). Within the 155°-distalized group, non-healed GT was linked to reduced ER compared to healed GT (-17° ± 6 vs. 20° ± 18, P=.006), while ROM and PROs were comparable in the 135° group regardless of healing status (P>.050).

CONCLUSION

Tuberosity healing with Univers Revers Total Shoulder System was more frequent with the 155°-distalized configuration, although functional outcomes were comparable to those achieved with the 135°-lateralized design. While successful tuberosity healing was critical to optimize shoulder rotation in the 155°-distalized group, healing had minimal influence on functional outcomes in the 135°-lateralized group.

摘要

背景

关于肱骨颈干角是否会影响肱骨近端骨折(PHF)的反式全肩关节置换术(rTSA)中结节愈合,仍存在争议。本研究旨在比较使用通用反式全肩关节系统的外侧化和远端化配置进行rTSA治疗PHF时的结节愈合率。次要目的是根据柄倾斜度和结节愈合状态评估功能结果。

方法

这项随机对照试验纳入了年龄≥65岁、患有Neer 3或4部分PHF或伴有骨质疏松症和/或肩袖撕裂的移位Neer 2部分PHF的患者。患者被随机分为两组:135°柄并向外移位4 mm或155°柄并向远端移位2.5 mm。预先的功效分析确定样本量为78例患者,以检测两组间结节愈合率有15%的差异且具有统计学意义。术后6个月、12个月和24个月时,由两名独立的肩关节外科医生通过X线片评估结节的愈合情况。比较了活动范围(ROM)和患者报告的结果(PROs)。PROs包括疼痛视觉模拟量表(VAS)、Constant-Murley评分(CMS)和上肢、肩部和手部功能障碍快速评估量表(Quick-DASH)。事后分析根据大结节愈合情况和植入物配置比较结果。

结果

共纳入79例患者,每组38例完成了至少2年的随访。155°远端化组有3例患者大结节未愈合,135°外侧化组有12例(P = 0.009)。术后24个月时,135°外侧化组大结节未愈合的相对风险与155°远端化组相比为4.0(95%可信区间:1.23 - 13.05,P = 0.022)。两组间的ROM和PROs相似(P > 0.050)。在大结节未愈合的病例中,155°远端化配置的外旋(ER)明显低于135°外侧化配置(-17°±6°对15°±19°,P = 0.006)。在愈合病例中,不同植入物类型之间的ROM和PROs未发现显著差异(P > 0.050)。在155°远端化组中,与愈合的大结节相比,未愈合的大结节与外旋降低有关(-17°±6°对20°±18°,P = 0.006),而在135°组中,无论愈合状态如何,ROM和PROs都具有可比性(P > 0.050)。

结论

使用通用反式全肩关节系统时,155°远端化配置的结节愈合更常见,尽管功能结果与135°外侧化设计相当。虽然成功的结节愈合对于优化155°远端化组的肩部旋转至关重要,但愈合对135°外侧化组的功能结果影响最小。

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